Status:
COMPLETED
Minimizing Immunosuppression in Old for Old Kidney Transplantation
Lead Sponsor:
University of Luebeck
Collaborating Sponsors:
Astellas Pharma GmbH
Conditions:
Kidney Transplantation
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To com...
Eligibility Criteria
Inclusion
- Patients receiving a cadaveric kidney transplant (first or re-transplant)
- Patients must met the criteria of the EUROTRANSPLANT program
- Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
- Written consent
Exclusion
- Not fulfilled inclusion criteria
- Cadaveric kidney from "non heart beating donors"
- One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
- Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
- Tacrolimus trough level \> 10ng/ml in three consecutive measurements
- Allergy against macrolide antibiotics or tacrolimus
- Systemic steroid therapy at study entry not related to transplantation
- History of Malignancy
- Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
- Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
- Patients under medication not approved by the German Ministry of Health
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00912678
Start Date
March 1 2002
End Date
October 1 2008
Last Update
June 3 2009
Active Locations (5)
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1
Transplant Center Cologne (Koeln-Mehrheim)
Cologne, Cologne, Germany, 51109
2
University of Essen - Transplant Center
Essen, Hesse, Germany
3
Charite- Transplant Center - Campus Mitte
Berlin, State of Berlin, Germany, 10117
4
Charite - Transplant Center - Virchow Clinic
Berlin, State of Berlin, Germany, 13353